Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery

Description

To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.

Conditions

Spinal Cord, Metastatic Epidural, Spine Stereotactic

Study Overview

Study Details

Study overview

To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.

Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery

Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery

Condition
Spinal Cord
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Greater than or equal to 18 years old
  • 2. Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
  • 3. Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
  • 4. All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and/or 0.01 cc of the cauda equina receiving 18-20 Gy. The goal of treatment is to select the minimal dose to the organ at risk which will achieve a GTV Dmin of 14 Gy at the treating physician's discretion.
  • 5. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
  • 6. All participants must be able to receive a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy
  • 7. All participants must have a vertebral level site of interest from C1 to S2
  • 8. Signed informed consent
  • 9. Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)
  • 10. Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression
  • 11. ECOG ≤ 2
  • 1. Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma)
  • 2. Prior history of radiation at the spinal site of interest
  • 3. Inability to lie supine comfortably for ≥ 60 minutes
  • 4. Progressive neurological deficits due to compression
  • 5. Inability of obtain an MRI
  • 6. Inability or refusal to undergo an MR simulation
  • 7. No eligible for single fraction SSRS for any reason
  • 8. Participants who are pregnant

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Amol Ghia, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2029-12-31